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Terminated

MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.

FDA Recall Z-0222-2015 · Posted 2014-11-17

Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeHQF
Date Initiated2013-05-24
Date Terminated2014-11-17
Product Quantity5

Reason for Recall

Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required.

Firm Action

Nidek Engineers visited all affected sites to install new software version. For questions regarding this recall call 510-353-7785.

Root Cause

Software design

Distribution Pattern

US Distribution in the states of: CA, NE, and NY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORNidek Incorporated · 2011-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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